Gina Catalano, RAC-Devices, RCC-MDR

*** REGULATORY ALERT *** A significant regulatory update from the Food and Drug Administration (#FDA) is about to take effect, the Cybersecurity Requirements for Medical Devices, Quality System Considerations and Content of Premarket Submissions Guidance, which emphasizes robust cybersecurity throughout the lifecycle of medical devices. What Changed? On December 29, 2023, the FDA introduced regulations mandating medical device manufacturers to integrate and maintain strong #cybersecurity measures. These regulations took effect on March 29, 2024, with two critical compliance milestones. New device submissions submitted for FDA approval on or after March 29, 2024, must immediately comply to be considered for approval. Existing devices produced by manufacturers have until December 31, 2024, to bring current devices into compliance. These measures aim to protect against vulnerabilities that could be exploited, ensuring medical devices remain safe, effective, and secure in a connected healthcare environment. Why Does This Matter? Cybersecurity risks in #healthcare are rising, with attacks targeting connected devices that manage sensitive patient data or critical functions. Devices such as insulin pumps, pacemakers, and imaging systems are particularly vulnerable. A breach can compromise data and pose life-threatening risks. The FDA’s requirements focus on proactive strategies such as threat modeling and risk assessments to evaluate vulnerabilities and implement mitigations before market release, as well as the use of secure design principles such as the use of encryption, authentication and regular software updates throughout the device's lifecycle. Timely implementation is essential to ensure regulatory compliance. What’s Next? With the December 31, 2024, deadline for existing devices fast approaching, now is the time to act. Manufacturers should assess their products, refine processes, and invest in the knowledge needed to meet these critical requirements. Compliance can be challenging, but it's critical for organizations to: -Understand regulatory requirements. -Build secure-by-design products. -Establish #incidentresponse plans tailored to medical devices. Don’t let cybersecurity be an afterthought. Contact us at #ThinkSecure to learn how we can support your journey toward #FDA #compliance and a more secure future for #medicaldevices. Reach out to us today to schedule a training session or workshop custom tailored to your needs.

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IPM took a multifaceted approach to EU MDR remediation, driving a medical device company to build the staffing, budget, governance, and operations necessary for the critical cross-functional effort. #EUMDR #FromStrategyToExecution https://lnkd.in/gFbzand9

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Learn more about PMS and PSUR requirements from our latest white paper by @Rachel PAUL. This white paper discusses the MDR requirements regarding PMS obligations and the risks resulting from their implementation in a global QMS. Download our white paper here: https://s.ul.com/3WkpdJ8 #medicaldevice #regulatoryaffairs #whitepaper #medtech #healthtech #biotech #EU #MDR #QMS #weareULSolutions

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Performing drug tests with devices that aren’t FDA-cleared is risky. With an FDA-cleared device, you can avoid compromised accuracy and legal issues in your testing processes and programs. That’s why the PharmChek® Sweat Patch stands out. It’s the only FDA-cleared wearable sweat patch on the market, with a proven track record since its clearance in 1990. Backed by decades of credibility, the PharmChek® Sweat Patch offers reliable, non-invasive, and tamper-evident drug testing—making it the trusted choice for long-term monitoring. Learn more at pharmchek.com. #PharmChek #DrugTesting #YouOnlySweatTheTruth

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Creating effective documentation for regulatory compliance is no easy task, but when done right, it’s an invaluable tool for any organization. Dive deeper into how a strong documentation structure supports compliance beyond control numbers and approvals in this month's Back to Basics column of Quality Progress. Read the full article at: https://lnkd.in/gJhYxpnC #QualityProgress #BackToBasics

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📢 WEBINAR ALERT! The FDA recently announced a staggered approach to its enforcement of enhanced DSCSA guidelines. However, many of these requirements are already in place. What does this update mean for you? Join us Wednesday, Nov. 20th for “FDA DSCSA Exemptions: What’s Next for Compliance?” Gain insights into DSCSA exemptions, key challenges, and how to keep your organization on track. Register at https://buff.ly/3YZ9XS3 #DSCSA #DQSA #Pharmacy #Compliance #PharmacyCompliance #Webinar

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The FDA’s final guidance establishes standards for data selection, validation, and quality to improve the reliability of using #RWD from #electronichealthrecords and #medicalclaims in #regulatory decisions for drugs, enhancing #RWE initiatives. Read at The Evidence Base® #heor #healtheconomics #outcomesresearch #realworldevidence #realworlddata #regulation #regulatoryaffairs #healthdata #healthpolicy #EHRs

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FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. The draft guidance provides recommendations on what is required to meet cybersecurity obligations under section 524B of the Food, Drug and Cosmetic Act (FD&C). Once finalized, the content from the draft guidance will be included within the existing cybersecurity premarket guidance. Lisa Baumhardt and Adrienne Lenz recently wrote a blog post about this guidance. Read their blog post here: https://lnkd.in/e3f46r6v #fda #fdalawblog #medicaldevices #cybersecurity

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❓ Why DocketScope? ✅ Here's what one Regulatory Policy Counselor has to say: "When a project has thousands, perhaps hundreds of thousands, of comments, quality control is imperative. DocketScope makes quality control and quality assurance easy." https://lnkd.in/eyE6G9UP #docketscope #regtech #betterregulation #regulation

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𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗙𝗗𝗔 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: 𝗦𝗲𝗰𝘁𝗶𝗼𝗻 𝟱𝟬𝟲𝗝 𝗘𝘅𝗽𝗹𝗮𝗶𝗻𝗲𝗱 🚨 Are you prepared to meet the FDA’s requirements under Section 506J of the FD&C Act? 🤔 𝗪𝗵𝘆 𝗶𝘁 𝗺𝗮𝘁𝘁𝗲𝗿𝘀: Section 506J mandates that manufacturers notify the FDA of permanent discontinuations or interruptions in production likely to disrupt the supply of critical medical devices during a public health emergency. 📉⚠️ This process is vital for mitigating shortages and protecting public health. 🏥 𝗞𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲: 🔹 Understand which devices require mandatory notification. 📑 🔹 Ensure timely and accurate compliance with FDA expectations. ⏰✅ 🔹 Discover additional voluntary actions to strengthen your supply chain resilience. 🔗💪 At Smart MDR, we specialize in guiding manufacturers through complex regulatory requirements to ensure compliance and safeguard market access. 🌍🔐 Access the full FDA guidance here: https://lnkd.in/dNiZZCZB 📘 Need help navigating these updates? Contact [email protected] 📧 #FDA #FDANEWS #FDAguidance #506J #MedicalDevices #FDACompliance #RegulatoryAffairs #RegulatoryCompliance #SmartMDR #4EasyPRRC

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𝗘𝘀𝘀𝗲𝗻𝘁𝗶𝗮𝗹 𝗙𝗗𝗔 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲: 𝗦𝗲𝗰𝘁𝗶𝗼𝗻 𝟱𝟬𝟲𝗝 𝗘𝘅𝗽𝗹𝗮𝗶𝗻𝗲𝗱 🚨 Are you prepared to meet the FDA’s requirements under Section 506J of the FD&C Act? 🤔 𝗪𝗵𝘆 𝗶𝘁 𝗺𝗮𝘁𝘁𝗲𝗿𝘀: Section 506J mandates that manufacturers notify the FDA of permanent discontinuations or interruptions in production likely to disrupt the supply of critical medical devices during a public health emergency. 📉⚠️ This process is vital for mitigating shortages and protecting public health. 🏥 𝗞𝗲𝘆 𝘁𝗮𝗸𝗲𝗮𝘄𝗮𝘆𝘀 𝗳𝗿𝗼𝗺 𝘁𝗵𝗲 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲: 🔹 Understand which devices require mandatory notification. 📑 🔹 Ensure timely and accurate compliance with FDA expectations. ⏰✅ 🔹 Discover additional voluntary actions to strengthen your supply chain resilience. 🔗💪 At Smart MDR, from 4 Easy PRRC, we specialize in guiding manufacturers through complex regulatory requirements to ensure compliance and safeguard market access. 🌍🔐 Access the full FDA guidance here: https://lnkd.in/dNiZZCZB 📘 Need help navigating these updates? Contact [email protected] 📧 #FDA #FDANEWS #FDAguidance #506J #MedicalDevices #FDACompliance #RegulatoryAffairs #RegulatoryCompliance #SmartMDR #4EasyPRRC

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FDA issues final guidance on communicating scientific information about unapproved uses This guidance describes FDA’s enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm’s approved/cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. The guidance describes the characteristics of the specific source publications contained in firm-initiated communications that fall within the enforcement policy outlined in this guidance.  #fda #guidance #unapproveddruguse #communication #scientific #information https://lnkd.in/gcJzT8nX

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Learn how RCA's regulatory compliance consultants approach an FDA inspection including inspection preparedness & behavioral training. Link Below ↓ https://ow.ly/wbiJ50THlmm

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⏰ The DSCSA deadline is approaching fast! Get expert tips on navigating this regulatory landscape in our upcoming webinar. Learn about compliance requirements, workflow impacts, and more. Secure your spot today! 📝 Wed, May 29th | 2:00 PM EST. Register: https://bit.ly/4b48hv6

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#NADAC lawsuits on the way? Following lower measured NADAC generic #drug invoice costs, National Association of Chain Drug Stores (NACDS) & National Community Pharmacists Association (NCPA) accuse CMS of "arbitrary and capricious" changes to methodology and sample. My $0.02: Improving NADAC's accuracy will hurt retail #pharmacies, so expect more battles. ==> https://drugch.nl/4cleCT9

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The 2024 jurisdictional Drug Trends reports are now live! You can view key findings from the Illicit Drug Reporting System (IDRS) and the Ecstasy and Related Drugs Reporting System (EDRS) interviews for each state and territory in the latest Drug Trends newsletter here: https://lnkd.in/g3t5-nQX

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What Happens if You Don't Have Any Unresolved Anomalies? FDA Quote: “Therefore, as recommended in the “Unresolved Software Anomalies” section of FDA’s guidance document “Content of Premarket Submissions for Device Software Functions”, please provide evaluation of the impact of the anomaly on the device’s safety and effectiveness, including operator usage and human factors considerations; and risk-based rationale for not correcting or fixing the anomaly in alignment with your risk management plan or procedure(s). Please also clarify how the end user would understand the impact of and workaround for this unresolved anomaly. It is important that appropriate measures have been taken to ensure anomalies will not affect safe and effective use of the device or result in adverse patient management." 💡Commentary: • Most software devices have anomalies (aka bugs), and the FDA expects you to document them 🐞 • This is a big change since 2019. It appears the FDA is requiring this for all devices (including software and non-software devices). • A common misconception among developers is that software needs to be free of bugs before you can get it cleared. This is not the case. The FDA understands software will likely always have bugs. • You must demonstrate to the FDA that you are thinking carefully about how the anomaly impacts safety or effectiveness. Then you must justify why you decided it is okay to leave the bug in the software. This may involve explaining how you plan to address the anomaly in a future software release, or that the risk of the anomaly is sufficiently low, or, that there is a workaround a user can implement.

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